Back to resultsAbemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)
Primary Purpose
Breast Neoplasm, Neoplasm Metastasis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Fulvestrant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
- On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
- On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
- Must be deemed appropriate for treatment with ET
- If female, have a postmenopausal status by natural or surgical means
- Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
- Have adequate renal, hematologic, and hepatic organ function
- Must be able to swallow capsules/tablets
Exclusion Criteria:
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have symptomatic or untreated central nervous system metastasis
- Have received any systemic therapy between disease recurrence/progression and study screening
- Have received more than 1 line of therapy for advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer (MBC)
- Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
Sites / Locations
- St. Joseph's Hospital and Medical Center
- Providence Medical Foundation
- Cancer and Blood Specialty Clinic
- Keck School of Medicine of USC
- TRIO-US (Translational Research in Oncology-US)
- UCLA Hematology/Oncology - Parkside
- Olive View-UCLA Medical Center
- Torrance Memorial Physician Network / Cancer Care
- PIH Health Hematology Medical Oncology
- Millennium Oncology - Hollywood
- University of Miami Hospital and Clinics, Sylvester Cancer Center
- Winship Cancer Institute, Emory University
- Northeast Georgia Medical Center
- Central Georgia Cancer Care
- Kapiolani Medical Center for Women and Children
- Ingalls Memorial Hospital
- Clinical Trials of SWLA
- Central Maine Medical Center
- Mfsmc-Hjwci
- Massachusetts General Hospital
- MGH Northshore Cancer Center
- Southcoast Centers for Cancer Care
- Dana-Farber Cancer Institute - Foxborough
- Dana Farber Cancer Center Merrimack Valley
- Reliant Medical Group
- St. Vincent Frontier Cancer Center
- University of New Mexico Comprehensive Cancer Center
- Lifespan Cancer Institute
- Sarah Cannon Research Institute/SCRI
- Texas Oncology - Bedford
- Parkland Health and Hospital System
- UT Southwestern Medical Center
- Texas Oncology - McKinney
- Texas Oncology-Plano West
- Mays Cancer Center
- US Oncology
- Intermountain Medical Center
- The University of Vermont Medical Center Inc.
- Shenandoah Oncology, P.C.
- Fundación Respirar
- Centro de Investigaciones Metabólicas (CINME)
- Fundación Cenit Para La Investigación En Neurociencias
- Instituto Médico Río Cuarto
- CER San Juan
- Algemeen Ziekenhuis klina
- Jessa Ziekenhuis
- Multiscan
- Fakultni nemocnice Hradec Kralove
- Herlev and Gentofte Hospital
- Regionshospitalet Herning
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
- Hôpital privé du Confluent SAS
- Institut Paoli-Calmettes
- Onkoradiologiai Kozpont
- Magyar Honvedseg Egeszsegugyi Kozpont
- Országos Onkológiai Intézet
- Soroka Medical Center
- Humanitas Istituto Clinico Catanese
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
- Korea University Guro Hospital
- Centro de Investigacion en Artritis y Osteoporosis SC
- COI Tijuana - Centro Oncológico Internacional
- Centro Oncológico Internacional (COI)
- Centro Regiomontano de Investigación
- Oncologico Potosino, S.C.
- Europejskie Centrum Zdrowia - Oddzial Onkologii
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
- Parc de Salut Mar - Hospital del Mar
- Hospital Clínic de Barcelona
- Complejo Hospitalario de Navarra
- Hospital Universitari Sant Joan de Reus
- Hospital Infanta Cristina
- Hospital Universitario de Toledo
- Karolinska Universitetssjukhuset Solna
- Chi Mei Medical Center
- Taipei Tzu Chi General Hospital
- Mackay Memorial Hospital
- Taipei Veterans General Hospital
- Izmir Medical Park Hospital
- Necmettin Erbakan Meram Medical Fac.
- Gulhane Egitim Arastirma Hastanesi
- Trakya University
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Abemaciclib plus Fulvestrant
Arm B: Placebo plus Fulvestrant
Arm Description
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Placebo administered orally in combination with fulvestrant administered IM.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
Investigator assessment
Secondary Outcome Measures
Overall Survival (OS)
OS
PFS
Blinded independent review
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
ORR
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
CBR
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD)
DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD
Duration of Response (DoR)
DoR
Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time to Deterioration in Physical Function
Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
PK: Mean Steady State Concentrations of Abemaciclib
Full Information
NCT ID
NCT05169567
First Posted
December 22, 2021
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05169567
Brief Title
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
Acronym
postMONARCH
Official Title
postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
February 16, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Abemaciclib plus Fulvestrant
Arm Type
Experimental
Arm Description
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Arm Title
Arm B: Placebo plus Fulvestrant
Arm Type
Active Comparator
Arm Description
Placebo administered orally in combination with fulvestrant administered IM.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Administered IM.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Investigator assessment
Time Frame
Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS
Time Frame
Randomization until death from any cause (estimated as up to 5 years)
Title
PFS
Description
Blinded independent review
Time Frame
Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Title
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
Description
ORR
Time Frame
Randomization until measured progressive disease (estimated as up to 1 year)
Title
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
Description
CBR
Time Frame
Randomization until measured progressive disease (estimated as up to 1 year)
Title
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD)
Description
DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD
Time Frame
Randomization until measured progressive disease (estimated as up to 1 year)
Title
Duration of Response (DoR)
Description
DoR
Time Frame
Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Title
Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Description
The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time Frame
Randomization through Follow-up (estimated as up to 3 years)
Title
Time to Deterioration in Physical Function
Description
Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.
Time Frame
Randomization through Follow-up (estimated as up to 3 years)
Title
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Description
PK: Mean Steady State Concentrations of Abemaciclib
Time Frame
Day 1 of Cycle 3 (Cycle = 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion Criteria:
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Have symptomatic or untreated central nervous system metastasis
Have received any systemic therapy between disease recurrence/progression and study screening
Have received more than 1 line of therapy for advanced or metastatic disease.
Have received prior chemotherapy for metastatic breast cancer (MBC)
Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Cancer and Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
TRIO-US (Translational Research in Oncology-US)
City
Los Angeles
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCLA Hematology/Oncology - Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Torrance Memorial Physician Network / Cancer Care
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
PIH Health Hematology Medical Oncology
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Millennium Oncology - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Central Georgia Cancer Care
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Clinical Trials of SWLA
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Mfsmc-Hjwci
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MGH Northshore Cancer Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Southcoast Centers for Cancer Care
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
Dana-Farber Cancer Institute - Foxborough
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
Dana Farber Cancer Center Merrimack Valley
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Reliant Medical Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01606
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Lifespan Cancer Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Sarah Cannon Research Institute/SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Texas Oncology-Plano West
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
The University of Vermont Medical Center Inc.
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Shenandoah Oncology, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Fundación Respirar
City
Buenos Aires
State/Province
Buenos Air
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Fundación Cenit Para La Investigación En Neurociencias
City
Caba
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1125
Country
Argentina
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
CER San Juan
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Algemeen Ziekenhuis klina
City
Brasschaat
State/Province
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Multiscan
City
Pardubice
State/Province
Pardubický Kraj
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Herlev and Gentofte Hospital
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Regionshospitalet Herning
City
Herning
State/Province
Midtjyllan
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Hôpital privé du Confluent SAS
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44277
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Provence-Alpes-Côte-d'Azur
ZIP/Postal Code
13273
Country
France
Facility Name
Onkoradiologiai Kozpont
City
Kecskemét
State/Province
Bács-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Soroka Medical Center
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8400000
Country
Israel
Facility Name
Humanitas Istituto Clinico Catanese
City
Misterbianco
State/Province
Catania
ZIP/Postal Code
95045
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Centro de Investigacion en Artritis y Osteoporosis SC
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
COI Tijuana - Centro Oncológico Internacional
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Centro Oncológico Internacional (COI)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45647
Country
Mexico
Facility Name
Centro Regiomontano de Investigación
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Oncologico Potosino, S.C.
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78209
Country
Mexico
Facility Name
Europejskie Centrum Zdrowia - Oddzial Onkologii
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Parc de Salut Mar - Hospital del Mar
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31009
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
State/Province
Tarragona [Tarragona]
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Hospital Universitario de Toledo
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
State/Province
Stockholms
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Chi Mei Medical Center
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Taipei Tzu Chi General Hospital
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Izmir Medical Park Hospital
City
Izmir, Karsiyaka
State/Province
İzmir
ZIP/Postal Code
009035575
Country
Turkey
Facility Name
Necmettin Erbakan Meram Medical Fac.
City
Meram
State/Province
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Gulhane Egitim Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3dpA0zpCRcFApMyAER3V1o
Description
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)
Learn more about this trial
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
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